薬理と治療
2013, 41巻Suppl 2
Volumes & issues:
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日本臨床試験研究会雑誌
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- 扉・目次
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- 第4回 日本臨床試験研究会学術集会
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【シンポジウム1●「生物統計 臨床試験におけるQOLと医療経済評価」】 イントロダクション―臨床試験における QOL と医療経済評価
41巻Suppl 2(2013);View Description Hide Description -
【シンポジウム1●「生物統計 臨床試験におけるQOLと医療経済評価」】 臨床試験における健康関連 QoL 評価の実例
41巻Suppl 2(2013);View Description Hide Description -
【シンポジウム1●「生物統計 臨床試験におけるQOLと医療経済評価」】 Development Program for the Japanese Version of the PRO-CTCAE
41巻Suppl 2(2013);View Description Hide DescriptionBackground The US National Cancer Institute(NCI)-Common Terminology Criteria for Adverse Events(CTCAE)is a longstanding empirically developed grading system designed for use in cancer clinical trials to aid clinicians in detecting and documenting an array of adverse events(AEs)commonly encountered in oncology. There is growing awareness that collecting symptom data directly from patients using patient-reported outcome(PRO)tools can improve the accuracy and efficiency of symptomatic AE data collection. The purpose of the NCI Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events(PRO-CTCAE)project is to develop a patient-reported outcomes measurement system to allow patients to self-report the symptomatic adverse events listed in the CTCAE, thus improving the accuracy and precision of grading symptomatic AEs. The development of a translation of the NCI PRO-CTCAE into Japanese serves an important role by enabling collection of symptomatic AE information from Japanese speakers. A project team (the PRO-CTCAE-J Working Group)was formed to accomplish the translation and Japanese linguistic validation, and to explore the feasibility and acceptability of using the NCI PROCTCAE-J in the Japanese clinical trials context. A material transfer agreement was established between Japanese investigators and the US NCI in order to conduct this work. Methods and Results Forward and back translations were performed and an independent review was performed by the Japan Clinical Oncology Group(JCOG)Executive Committee. We conducted cognitive interviews in a range of treatment settings among diverse groups of cancer patients. Participants were asked to self-complete the PRO-CTCAE and then were interviewed using semi-structured scripts and predetermined probes to determine whether any items were difficult to comprehend and/or not relevant to their symptoms. We are currently analyzing results of the interviews. PRO-CTCAE is being administered in an international randomized controlled trial(NCCTG0949/JCOG1018). Before JCOG1018 opened, we conducted a feasibility evaluation in 16 patients, to assure that patients were willing and able to report this information in a timely manner. There were no missing data and feasibility of the measurement was confirmed. The physicians’reports tended to underestimate than the patients’reports as previously published elsewhere. We are currently planning a validation study to examine the reliability and validity of the Japanese language translation of the PROCTCAE. Conclusion We are continuing the development process under the provisions of a material transfer agreement with the US NCI and plan to have a translated and linguistically validated NCI PRO-CTCAE-J(Japanese language)available for use in Japanese clinical trials settings. -
【シンポジウム1●「生物統計 臨床試験におけるQOLと医療経済評価」】 臨床試験における医療経済評価でできること・できないこと
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【シンポジウム 2●臨床試験のモニタリングはどうあるべきか?】 米国の IND trial,日本の医師主導治験でのモニタリングの現状
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【シンポジウム 2●臨床試験のモニタリングはどうあるべきか?】 日本での企業治験,臨床研究でのモニタリングの現状
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【シンポジウム 2●臨床試験のモニタリングはどうあるべきか?】 グローバル治験を踏まえた日本での臨床試験におけるモニタリングのあり方
41巻Suppl 2(2013);View Description Hide Description - Series
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EQUATOR Network から得られる,質の高い研究報告のための国際ルール― ② CONSORT statement:ランダム化並行群間比較試験報告のためのガイドラインとその拡張版
41巻Suppl 2(2013);View Description Hide Description - CONGRESS REPORT
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文部科学省 橋渡し研究加速ネットワークプログラム平成 24 年度成果報告会「イノベーションをマーケットへ」
41巻Suppl 2(2013);View Description Hide Description - Original Article
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研究者主導臨床試験におけるローカルデータマネジメントの質と CRC 有無・登録症例数の関連
41巻Suppl 2(2013);View Description Hide DescriptionBackground Some problems may occur while collecting data during clinical trials. For example, case report forms(CRF)may not be submitted or data errors are present in the submitted CRF. These problems adversely affect the reliability of the results, cost of the trial, and the time required for publication. However, these problems should decrease by sufficient local data management. A few detailed studies have analyzed the process from data collection to solving problems. However, the situations in which problems tend to occur are unclear, and the local data management is insufficient. Methods We investigated problems that occurred in a past investigator-initiated clinical trial. Percentage of CRF deficiency, incidence rate of data errors, and the number of days required for participating physicians to answer queries during the trial were calculated. We focused on the involvement of a clinical research coordinator(CRC)and the number of patients registered per physician as factors influencing these problems;we explored the association between frequency of problems and these factors. Results Although the trend was not monotonic, physicians who did not submit CRFs, who had many data errors, and who took a long time to answer queries tended to be those who had not received the CRC support or those who had a small number of patients registered. Conclusion CRC support and the number of registered cases were associated with the response time required and the percentage loss of CRFs near the maximum value. Data errors tended to decrease if CRC support was provided or the number of registered cases was large. - Case Report
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中央モニタリングによる治験業務の効率化に関する提案オペレーションセンターとプロジェクトポータルサイトを応用した集約化
41巻Suppl 2(2013);View Description Hide DescriptionObjectives We propose a concrete model of IT using central monitoring system, to optimize the process of clinical trial. Methods We assessed every process of current monitoring practices and discriminated the process which can be conducted by Off Site monitoring. Furthermore, we researched more efficient monitoring practices by consolidated information and use of IT system. Result We proposed the Project Portal Site for the institutions, sponsors, CROs and SMOs to share and exchange all study related information. Sponsor’s Operation Center manages the Project Portal Site and conducts the Off Site monitoring. We listed the functions of Project Portal Site and tasks of Operation Center. We estimated that this model is able to reduce the monitoring practices more than 40%compare to the ordinary practice. Conclusion The proposed IT based central monitoring system might be able to contribute to improve the quality in terms of information sharing and consolidation by drastic reduction of monitoring related number of man-hour. -
大阪大学医学部附属病院における臨床研究に関連した問い合わせおよび相談内容の検討
41巻Suppl 2(2013);View Description Hide DescriptionBackground Since revision of the Japanese Ethical Guidelines for Clinical Studies(EGCS)in 2008, researchers are required to perform their clinical studies in accordance with the EGCS. The staff of the Ethical Review Board is asked various questions from researchers. Objectives To enhance the support system and enable clinical studies to be promptly and properly carried out, we analyzed the researcher’s questions. Methods We investigated the questions and consultations in regards to the time taken to answer the questions, the inquiry method and the content of each question collected from July to September 2012. Results The number of questions and consultations were on average 100 per month. Researchers were asking the Ethical Review Board EGCS related questions, as well as, the method of application, protocol design, procedure for obtaining informed consent, conflict of interests, insurance, etc... Conclusions In order for researchers to implement high quality research, we will reflect the analyzed questions as part of the researcher’s training, and will change the application form to facilitate filling it out correctly. Furthermore, we think that it is necessary to cooperate closely with persons in charge relevant to implementation of research. - Review Article
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- 会員連絡
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活動報告および活動予定/JSCTR 認定 GCP パスポート試験 試験対策問題集 発売のお知らせ
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